Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Fatigue Clinical Trial

Official title:

A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669460
• Other study ID #: 12-5041-C
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2012
• Last updated: December 18, 2013
• Start date: July 2012

Study information

• Verified date: December 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University Health Network Research Ethics Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed prostate cancer

• Currently receiving LHRH-agonist therapy for greater than 6 months

• Measurable fatigue, defined as a score of = 2 on the Bruera global fatigue severity scale

• Able to swallow Red Bull™ Sugar-Free Drink

• Life expectancy of at least 1 year

• Able to read and write in English

• Willing to limit consumption of alcohol to one drink per day

Exclusion Criteria:

• Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)

• Myocardial infarction within past 6 months

• Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders

• Evidence of drug or alcohol abuse

• Known hypersensitivity to caffeine

• Known history of liver and kidney insufficiencies

• Known contraindications to Red Bull™ use

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in overall fatigue as measured by Bruera global fatigue severity scale.		Within 4 days after completion of intervention (28 days of Red Bull™)	No
Secondary	Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)		Within 4 days after completion of intervention (28 days of Red Bull™)	No